Prevention of recurrent foot ulcers with plantar pressure-based in-shoe orthoses: the CareFUL prevention multicenter randomized controlled trial.

Abstract

OBJECTIVE:

To assess the efficacy of in-shoe orthoses that were designed based on shape and barefoot plantar pressure in reducing the incidence of submetatarsal head plantar ulcers in people with diabetes, peripheral neuropathy, and a history of similar prior ulceration.

RESEARCH DESIGN AND METHODS:

Single-blinded multicenter randomized controlled trial with subjects randomized to wear shape- and pressure-based orthoses (experimental, n = 66) or standard-of-care A5513 orthoses (control, n = 64). Patients were followed for 15 months, until a study end point (forefoot plantar ulcer or nonulcerative plantar forefoot lesion) or to study termination. Proportional hazards regression was used for analysis.

RESULTS:

There was a trend in the composite primary end point (both ulcers and nonulcerative lesions) across the full follow-up period (P = 0.13) in favor of the experimental orthoses. This trend was due to a marked difference in ulcer occurrence (P = 0.007) but no difference in the rate of nonulcerative lesions (P = 0.76). At 180 days, the ulcer prevention effect of the experimental orthoses was already significant (P = 0.003) when compared with control, and the benefit of the experimental orthoses with respect to the composite end point was also significant (P = 0.042). The hazard ratio was 3.4 (95% CI 1.3-8.7) for the occurrence of a submetatarsal head plantar ulcer in the control compared with experimental arm over the duration of the study.

CONCLUSIONS:

We conclude that shape- and barefoot plantar pressure-based orthoses were more effective in reducing submetatarsal head plantar ulcer recurrence than current standard-of-care orthoses, but they did not significantly reduce nonulcerative lesions.

• Authors: Jan S Ulbrecht, Timothy Hurley, David T Mauger, Peter R Cavanagh
• Journal: Diabetes care (Diabetes Care) Vol. 37 Issue 7 Pg. 1982-9 (Jul 2014) ISSN: 1935-5548 [Electronic] United States
• PMID: 24760263 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
• Copyright: © 2014 by the American Diabetes Association.

Topics

• Adult
• Aged
• Aged, 80 and over
• Diabetes Mellitus (physiopathology)
• Diabetic Foot (pathology, prevention & control)
• Female
• Follow-Up Studies
• Foot
• Foot Ulcer (etiology, pathology, prevention & control)
• Humans
• Male
• Middle Aged
• Orthotic Devices
• Peripheral Nervous System Diseases (complications)
• Pressure
• Secondary Prevention
• Shoes
• Single-Blind Method